UNIVAX FOCUSES RESOURCES ON CORE ANTIBODY CAPABILITIES; REDUCES EXPENSE RATE; Shifts Emphasis in Staphylococcus Program from Vaccine to Antibody.ROCKVILLE, Md.--(HealthWire)--May 15, 1995--Univax Biologics, Inc. (Nasdaq: UNVX) today announced it has restructured its business operations in order to optimize its marketing and drug development efforts and reduce expenses. The Company will concentrate its resources on maximizing the market introduction of WinRho SD(TM) (Rho (D) Immune Globulin Immune globulin Serum containing antibodies against a specific infection. Mentioned in: Maternal to Fetal Infections Intravenous (Human)) and on developing its two lead specific polyclonal antibodies, HyperGAM+(TM)CF for cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. patients and StaphGAM(TM) for the prevention of Staphylococcus staphylococcus (stăf'ələkŏk`əs), any of the pathogenic bacteria, parasitic to humans, that belong to the genus Staphylococcus. The spherical bacterial cells (cocci) typically occur in irregular clusters [Gr. infections in hospitalized patients. To support this move, the Company will shift its drug development efforts for the prevention of Staphylococcus infections from its StaphVAX(TM) vaccine to focus on its StaphGAM antibody product. As a result of this strategic restructuring, the Company will reduce its personnel by approximately 25 percent. The staff reductions will occur throughout the organization and will affect approximately 40 employees. These staff reductions, in combination with other actions being pursued by the Company, are designed to reduce the Company's annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. burn rate by more than 40 percent. The changes will not affect the launch plans or timeline for putting WinRho SD on the market. "Focusing our human and financial resources on our core competency - the development and commercialization of specific polyclonal antibody products - is in the best long-term interests of the Company," stated Thomas P. Stagnaro, Univax President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We believe this sharper focus will capitalize on Univax's extensive capabilities in donor stimulation using advanced immunizing agents. This will maximize our ability to develop timely solutions to pressing medical needs, both on our own and in cooperation with corporate partners." The decision to concentrate the Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes product development efforts on StaphGAM was based in part on an analysis of 25 percent of the data from the recently completed Phase II trial of StaphVAX in peritoneal dialysis peritoneal dialysis n. The removal of soluble substances and water from the body by transfer across the peritoneum, utilizing a solution which is intermittently introduced into and removed from the peritoneal cavity. patients. Based on this preliminary analysis, the Company has concluded that a more immunogenic im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. dosage formulation must be developed to achieve more satisfactory antibody levels in kidney dialysis patients before entering Phase III efficacy trials. The Company expects to complete analyzing the StaphVAX Phase II trial data in the third quarter of 1995. "Since StaphVAX is the only product outside our strategic focus on specific polyclonal antibodies, the Company has decided the additional effort required to develop the vaccine is not the best use of our resources at this time," said Mr. Stagnaro. "We will therefore concentrate our efforts on obtaining initial evidence of clinical efficacy using StaphGAM. This decision is supported by recent encouraging pre-clinical results with the antibody in animal bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. and endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. models and Phase I clinical studies indicating that new immunizing agent formulations can achieve higher antibody levels in healthy subjects." Univax Biologics, founded in 1988, is a biopharmaceutical company engaged in the development of products that prevent and treat infectious diseases and related complications through activation and targeting of the human immune system. The Company's product pipeline is principally composed of specific polyclonal antibodies for short-term protection and therapeutic intervention. Univax is now launching its first product, WinRho SD, which recently received U.S. marketing clearance. CONTACT: Univax Biologics, Inc., Rockville Judith A. Hautala, Ph.D., 301/770-3099 or Burns McClellan, New York Reagan Codner (Investor inquiries) or James W. Heins (Media inquiries), 212/505-1919 |
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